SBIR Phase I: Development of a Molecular Diagnostic Platform for Use at Home without an Expensive Table-top Device

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel molecular diagnostic platform for detecting respiratory diseases including strep throat. The innovation aims to provide the equivalent accuracy of laboratory-based tests for use by non-health care professionals in non-clinical settings. By enabling rapid and reliable pathogen detection at home, the platform aims to reduce the burden on healthcare facilities, offer convenience to patients, and improve timely access to treatment including rural or underserved areas where traditional healthcare access is limited. The anticipated technical outcomes include a disposable, user-friendly test that provides highly specific and sensitive results comparable to laboratory tests, thereby positioning this platform as a novel solution for in home-based molecular diagnostics for the total at-home molecular testing market, estimated to be worth $10B. This Small Business Innovation Research (SBIR) Phase I project focuses on developing a molecular diagnostic platform that leverages a novel combination of isothermal amplification and pH-sensitive polymers to detect specific bacterial DNA in saliva samples. The company’s molecular-based DNA test uses Loop-mediated Isothermal Amplification successfully utilized for other diagnostic applications, with the company’s proprietary pH-sensitive polymer formulation to operate effectively under a variety of conditions. The specific technology development objectives include optimizing the diagnostic sensitivity of the platform's polymer-based detection mechanism and ensuring robust performance at room temperature and elevated temperatures necessary for the molecular reactions. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.